A Study of GDC-0449 (Hedgehog Pathway Inhibitor) With Concurrent Chemotherapy and Bevacizumab As First-Line Therapy for Metastatic Colorectal Cancer - NCT00636610-20735 (Clinical Trial 209124)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy209124.aspx
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Clinton |
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State:
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MD |
| Zip Code: |
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20735 |
| Conditions: |
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Metastatic Colorectal Cancer |
| Purpose: |
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This is a randomized, placebo-controlled, double-blind study of GDC-0449 added to
biochemotherapy standard-of-care regimens for metastatic CRC, with treatment until disease
progression. Patients will receive either FOLFOX or FOLFIRI chemotherapy with bevacizumab.
The decision of which regimen (FOLFOX or FOLFIRI) to use will be made by the treating
physician and patient. Patients will be randomized to receive GDC-0449 or placebo and will
be stratified based on the chemotherapy regimen chosen and whether or not Response Evaluation
Criteria in Solid Tumors (RECIST) measurable disease is present at baseline.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
- Age ≥ 18 years
- Histologically confirmed metastatic colorectal cancer (CRC)
- Representative tumor specimens in paraffin blocks (preferred) or at least 15 unstained
slides, with an associated pathology report, must be confirmed to be available and
requested at any time prior to entry of study
- ECOG performance status 0 or 1
- Adequate hematopoetic capacity
- Adequate hepatic function
- Adequate renal function
- Use of an effective method of barrier contraception (for women of childbearing
potential)
- Signed informed consent
Exclusion Criteria:
- Prior chemotherapy for metastatic CRC or adjuvant chemotherapy for CRC within the
prior 6 months
- Clinically suspected or confirmed CNS metastases or carcinomatous meningitis
- Major surgical procedure within 4 weeks prior to Day 1
- Pelvic radiation within 2 weeks prior to Day 1
- Wound dehiscence requiring intervention, gastrointestinal perforation, or bowel
obstruction
- Pregnancy or lactation
- Uncontrolled medical illnesses including the following: infection requiring
intravenous (IV) antibiotics; congestive heart failure not controlled with medication;
hypertension not controlled with medication
- Thromboembolic disease
- History of other disease, metabolic dysfunction, physical examination finding, or
clinical laboratory finding giving reasonable suspicion of a disease or condition that
contraindicates use of an investigational drug or that might affect interpretation of
the results of the study or render the patient at high risk from treatment
complications |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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September 1, 2009 |
Modifications to
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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